FDA Proposes Food Safety Rules

Every year, 3000 Americans die from a food-borne illness. To combat this threat, the FDA recently proposed two food safety rules pursuant to the 2011 Food Safety Modernization Act (FSMA).

The first proposed rule would compel food-makers selling goods in the United States to create formal plans to prevent their products from causing illness. Covered entities would also be directed to monitor their facilities for biological hazards, address any problems that may arise, and document any corrective actions taken. The rule would also require facilities with a substantial risk of developing health hazards to implement mechanisms to prevent such hazards from materializing.

The FDA proposes that large businesses be given one year to comply after the publication of the final rule. Smaller businesses would have more time to comply with the regulation.

The second proposed rule would create enforceable, science-based safety standards for produce production on farms. The regulation would require any water likely to come in contact with crops to be safe and sanitary. It also would call for covered entities to test every batch of spent irrigation water for E. Coli and Salmonella and to take appropriate action if either micro-organism is detected.

The proposed rule would also address the potential contamination of soil through animal or human waste. In order to avoid exposure to disease from livestock, the proposed rule suggests a waiting time between animal grazing and the harvesting of covered produce.

In addition to addressing farming conditions, the proposed rule would require the establishment of qualification and training requirements for employees likely to handle produce.

The second proposed rule would apply to both domestic and foreign-grown produce. However, the proposed rule contains several exemptions. It would not apply to goods that are not raw agricultural commodities, goods produced for personal consumption, or goods that are generally cooked before consumption. The rule also exempts produce that already receives commercial processing if the processing significantly reduces the presence of dangerous microorganisms.

The two proposed rules are the product of a two-year outreach effort to the produce industry and consumer community. During this time, agency staff visited farms and held hundreds of meetings with interested parties. The proposed regulations follow other rules promulgated in 2011 pursuant to the FSMA. One such rule allows the agency to detain food if it has credible evidence that the food was contaminated or mislabeled in a potentially dangerous way. Another rule requires food importers to inform the Agency if another country has previously refused the imported product.

The FDA’s two new proposed rules will be available for public comment until May 16, 2013.